Global Director, Surgical Ophthalmic Clinical Development

Bausch + Lomb; Lincoln (NE); Sur place; USD 165 000 - 215 000; Plein temps

Avantages offerts par ce poste

Incentives program

Health, dental, vision insurance

401(k) with company match

Résumé du poste

Bausch + Lomb seeks a Director, Surgical Clinical Development to lead global clinical strategies for its ophthalmic surgical device portfolio. The role designs clinical evidence programs to support regulatory submissions and product launches, guiding feasibility through post-market studies across multiple regions.

The incumbent will partner with R&D, Regulatory, Quality, and Commercial teams, manage budgets, and cultivate relations with investigators and KOLs to sustain leadership in surgical

Qualifications

• Advanced degree in clinical/biomedical science.
• 7+ years in medical device clinical development (ophthalmic surgery).
• Experience leading global clinical strategy and regulatory submissions for surgical devices.
• Strong understanding of GCP and ISO 14155 and global regulatory frameworks.

Responsabilités

• Lead global clinical development strategy for surgical device programs from early-stage concept through post-market activities.
• Serve as clinical voice on global regulatory submissions, aligning with FDA, EU MDR/CE Mark, NMPA, PMDA pathways.
• Design and oversee clinical trials (feasibility, pivotal, post-approval) across diverse markets.
• Set direction, aligning clinical research priorities with company objectives and timely evidence delivery.
• Develop and author regulatory/clinical documents (investigation plans, protocols, reports, submission dossiers).
• Collaborate with R&D, Regulatory, Quality, and Commercial to translate insights into product development/ go-to-market strategies.
• Cultivate relationships with investigators, KOLs, and global regulatory experts.
• Oversee regulatory collaboration with global teams and support successful submissions.
• Lead or contribute to project strategy teams ensuring cross-functional alignment.
• Support market-expansion with evidence-generation strategies for various markets.
• Oversee due diligence and contribute to acquisitions/licensing input.
• Support vendor oversight and clinical operations planning.
• Contribute to best practices, SOPs, and globally harmonized clinical development programs.
• Manage budgets and resources, ensure timely trial data submissions.
• Identify and mitigate risks in clinical research activities.

Connaissances

Leadership

Clinical strategy

Regulatory submissions

Regulatory awareness

Project management

Communication

GCP/ISO 14155 knowledge

Formation

MD/OD/PhD or equivalent

Description du poste

Bausch + Lomb seeks a Director, Surgical Clinical Development to lead global clinical strategies for its ophthalmic surgical device portfolio. The role designs clinical evidence programs to support regulatory submissions and product launches, guiding feasibility through post-market studies across multiple regions.

The incumbent will partner with R&D, Regulatory, Quality, and Commercial teams, manage budgets, and cultivate relations with investigators and KOLs to sustain leadership in surgical